Bupropion for Smoking Cessation During Pregnancy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-12-31

Brief Summary

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This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

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Detailed Description

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This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects regardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month postpartum period. Subject participation will begin between 13-30 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13) months in length.

Conditions

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Pregnancy Related Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bupropion SR + cessation counseling

Bupropion SR and smoking cessation counseling Subjects received Bupropion SR 150 mg tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose Bupropion SR 150 mg tablet orally BID for a total medication treatment of 12 full weeks.

Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.

Group Type ACTIVE_COMPARATOR

Bupropion SR

Intervention Type DRUG

Bupropion SR 150 mg tablet

Smoking Cessation Counseling

Intervention Type BEHAVIORAL

35-min counseling by trained research nurse

Placebo + cessation counseling

Placebo and smoking cessation counseling Subjects received matching Bupropion SR placebo tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose matching Bupropion SR placebo tablet orally BID for a total medication treatment of 12 full weeks of therapy.

Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.

Group Type PLACEBO_COMPARATOR

Smoking Cessation Counseling

Intervention Type BEHAVIORAL

35-min counseling by trained research nurse

Placebo

Intervention Type DRUG

Matching Bupropion SR placebo tablet

Interventions

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Bupropion SR

Bupropion SR 150 mg tablet

Intervention Type DRUG

Smoking Cessation Counseling

35-min counseling by trained research nurse

Intervention Type BEHAVIORAL

Placebo

Matching Bupropion SR placebo tablet

Intervention Type DRUG

Other Intervention Names

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Zyban buproban Behavioral counseling Control

Eligibility Criteria

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Inclusion Criteria

* smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days
* 13-30 weeks gestation
* ≥18 years of age
* able to speak English or Spanish
* intent to carry pregnancy to term
* stable residence

Exclusion Criteria

* current illicit drug or alcohol abuse or dependence
* twins or other multiple gestation
* treatment for psychiatric disorder within the last 6 months
* unstable medical problems (eg, hypertension (BP\>140/90), preeclampsia, threatened abortion, hyperemesis gravidarum)
* known congenital abnormality
* seizure disorder
* use of psychotropic medication
* use of medication known to lower the seizure threshold
* anorexia/bulimia
* a personal history of closed head trauma with \> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion
* use of any other smoking cessation treatment in the past 30 days
* current enrollment in methadone treatment program
* prior pregnancy with preeclampsia diagnosis
* chronic hypertension (past history or current diagnosis)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No